Florida Patent Lawyer Blog

The unfortunate death of Michael Jackson and the trial of Dr. Conrad Murray has made a little-known drug, propofol (marketed as Diprivan by AstraZeneca), into a household name. What is fundamentally important about drugs like propofol may not only be what they're used for but their impact on the economy.

Propofol was originally developed in the UK by Imperial Chemical Industries (see U.S. Patent No. 4056635). Though clinical trials followed in 1977, due to negative reactions, the formulation was withdrawn from the market and subsequently reformulated as an emulsion of a soya oil/propofol mixture in water. The emulsified formulation, which is not a complex formula, was relaunched in 1986 by ICI (now AstraZeneca) under the brand name Diprivan. Propofol emulsion is a highly opaque, white fluid due to the scattering of light from the tiny oil droplets that it contains. There are 4 patents (5714520, 5731355, 5731356, 5908869) for Diprivan that are set are to expire in 2015.

The relatively simple formula for Diprivan, which generates annual sales of $400 - $500 Million for AstraZeneca, may make it easy for generics to enter the propofol market. True generics are not expected until 2015, but generics with different formulas are expected to come to market before 2015. It has been reported that propofol is a low profit-margin product. Thus, once generic-like products and generics hit the market, the margins will likely fall further. This brings up fundamental questions about the patent system. Should patent protection be extended in order to protect a patent owner's investment in a drug? Inventors and investors must justify the return on investment (ROI) on millions and billions of dollars spent on developing new drug products, otherwise, they simply won't do it anymore. Is 20 years enough time to obtain an adequate return on those large R&D expenditures? For instance why has Pfizer drastically cut its research and development spending and why has Amgen decided to buy back $5 billion of its stock? Are those indications that they don't have the incentive to invest in new products?

Creating an incentive to invent, via recovery of R&D expenditure and production of profits, is the premise of the U.S. patent system. We would be wise to review the current system to make sure this is still the case.

Continue reading "Propofol and the Economy" »

In an interesting decision today, the Board of Patent Appeals and Interferences (BPAI) decided that dosages are, for the most part, obvious. The case of Ex parte Gillis (Appeal 2010-009318) involved method claims for administering a medical therapy. Fundamental to the claims was a recitation of the dosage necessary to appropriately treat the patient. Assuming the medicine itself is prior art, does specific dosage data give your invention enough novelty?

The BPAI provided the following recitation of case law:

It is well settled that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).

In general, however, "an applicant may overcome a prima facie case of obviousness by establishing 'that the [claimed] range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.'" In re Peterson, 315 F.3d at 1330 (quoting In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997).

That spells it out pretty clearly - discovery of a dosage value for a known medicine is obvious, unless you can show unexpected results. Consequently, the BPAI provided the following decision in the Ex parte Gillis case:

[G]iven the broad range of useful dosages described in Wappler, we are not persuaded that the Examiner has failed to provide an adequate evidentiary basis for concluding that an ordinary artisan practicing Wagemans' continuous delivery method would have optimized the sufentanil dosage. As Appellants point us to no evidence that the dosage recited in claim 28 provides an unexpected result, and is therefore critical, see Peterson, 315 F.3d at 1330, we are not persuaded that the claimed dosage would have been unobvious over the cited references, despite the fact that the two cited references do not appear to describe the same route of drug administration.

Therefore, the Examiner's rejection was affirmed. As an aside, note that even though the prior art disclosed a different drug delivery method, this was not enough to distinguish the claims from the prior art.

What does this mean for patent practitioners? It means that when prosecuting drug therapy patent applications, you should rely on more than dosage data to distinguish the invention over the prior art, unless you can show unexpected results. Without the proper evidence supporting unexpected results, dosage data does not, by itself, provide enough novelty to an otherwise known medicine or therapy.

Continue reading "Board of Patent Appeals Decides on Obviousness of Dosages" »

In an interesting decision today at the Board of Patent Appeals and Interferences (BPAI), the Board found in favor of the Applicant with regard to a rarely used rejection based on res judicata.

The case of Ex parte Aggarwal (Appeal No. 2010-011553) involved error detection software for hypertext. There was an earlier appeal where the Appellant made a first patentability argument with regard to claims 1-5 and the Board affirmed the Examiner's rejection of claims 1-5. The result of the earlier appeal was that the Board remanded back to the Examiner with regard to other claims.

On remand, the Appellant did not amend claims 1-5 but made different patentability arguments for those claims. Since claims 1-5 did not change since the earlier appeal, the Examiner rejected claims 1-5 based on res judicata, stating that the Board already rejected claims 1-5 in a previous proceeding. This led to the second appeal, and this decision.

The Board framed the issue like so:

the dispute before us hinges on whether Appellants' failure to raise a particular patentability issue before the Board in the earlier appeal based on evidence that was entered and considered by the Examiner during prosecution before that appeal can be presented in a later appeal to effectively create a new record and thus present new patentability questions involving the same claims and rejections to avoid res judicata.

The answer to that question is yes. If an Appellant fails to raise a certain issue of patentability in an earlier appeal, he can still raise it in a later appeal of the same claims, even if the supporting evidence was present before the earlier appeal.

The BPAI noted the following case law:

"Res judicata" is "[a]n issue that has been definitively settled by judicial decision. . . . The three essential elements are (1) an earlier decision on the issue, (2) a final judgment on the merits, and (3) the involvement of the same parties, or parties in privity with the original parties." BLACK'S LAW DICTIONARY 1425 (9th ed. 2009) (citing RESTATEMENT (SECOND) OF JUDGMENTS §§ 17, 24 (1982)). When Appellants submit new affidavits not considered previously to make a new record, thus presenting different questions of patentability, the doctrine of res judicata does not apply "even if the claims are viewed as identical to those in the prior case." In re Russell, 439 F.2d 1228, 1230 (CCPA 1971).

The Board felt that the new issue of patentability was not previously heard, considered or decided upon, which is a required element of res judicata. The Board stated "Although the evidence on which this issue turns was previously entered and considered by the Examiner before the earlier appeal, it was simply not germane to the issues raised in the earlier appeal and, not surprisingly, not discussed by Appellants, the Examiner, nor the Board in connection with that appeal." As a result, the Board found that the res judicata doctrine did not apply to claims 1-5 and the rejection of claims 1-5 based on the res judicata doctrine was reversed.

What does this mean for practitioners? This means that you can get a do-over at the Board. Specifically, if you lose at the BPAI for a first set of claims, and you can somehow make it back to the Board, you can re-argue the rejection of the first set of claims, as long as you bring up new issues of patentability. Of course, this isn't the easiest route to get claims allowed. The wait time to get to the Board is at least 2 years for each round. But it's nice to know that you have the flexibility to bring up new issues in a later appeal. You are not locked out by the Board's previous unfavorable decision.

Post Script: the Board ended up rejecting claims 1-5 on obviousness grounds, leaving nothing for the Appellant.

Continue reading "Board of Patent Appeals Rules on Res Judicata Rejection" »

There are a number of mugshot web sites that publish publicly-available mugshots and then charge you to take them down. According to this news report, the florida.arrests.org web site, for example, will only remove certain mugshots in exchange for payment. In addition to being ethically questionable - to put it lightly - these web sites may also be violating Florida's right of publicity.

Florida recognizes an independent common law right protecting economic interests in a person's likeness. Florida has also codified this right in Florida Statute 540.08: 

Unauthorized publication of name or likeness.--
(1) No person shall publish, print, display or otherwise publicly use for purposes of trade or for any commercial or advertising purpose the name, portrait, photograph, or other likeness of any natural person without the express written or oral consent to such use ...

Thus, Florida's publicity law enables individuals to protect themselves from unauthorized commercial appropriation of their personas. Of course, the statute does provide exceptions for news organizations and other such reasons. But it is important to note that the right of publicity is generally regarded as a property right. Damages in publicity cases are measured by the commercial injury to the business value of personal identity. J. Thomas McCarthy says: "The right of publicity is not . . . just another kind of privacy right. It . . . is a wholly different and separate legal right." 19 COLUM.-VLA J.L. & ARTS 129. Infringement damages, therefore, are determined by the fair market value of the plaintiff's identity, the infringer's profits, and damage to the licensing opportunities for the plaintiff's identity.

In the case of the mugshot sites mentioned above, the sites are generating revenue using other's photographs. So it is clearly a commercial activity or for commercial purposes, as defined in the Florida statute above. But is it also a news organization providing newsworthy subject matter? Many would say not. But the state of the law on blogs, tweets and other new media is in a state of flux and will not be settled for quite some time. With regard to damages, web search results can certainly cause damage, especially in cases where the subject of a mugshot is looking for employment or seeking admission to a school. A mugshot could kill such prospects for a job-seeker or prospective student. So these mugshot sites are operating at their own peril.

If someone in Florida has been damaged or will be damaged by a mugshot on one of these web sites, they should hire an attorney that is familiar with the Florida right of publicity.

Continue reading "Mugshot Sites May Violate Florida's Right of Publicity" »

Companies like Eastman Kodak sell products that are protected by valuable patents. The importance of the patents used to protect these products is highlighted by Kodak's recent financial troubles. Kodak, with a current market cap of about $295 million, might only be able to save itself by selling a portfolio of 1,100 digital imaging patents for an estimated $2-$3 Billion.

Kodak obtained one of its first patents (No. 1588082) in 1926. The invention was aimed at creating a photographic process that could fit into a portable, small box. Kodak went on to become one of the biggest patent filers in history. Consequently, Kodak's name became synonymous with photography for the better part of a century. But since the late 1900s, Kodak's dominance in the film business has been replaced by new technology. Due to the change in photographic technology and heavy competition, the Kodak name seems to have lost its prestige. But although the name may have less value these days, the patent royalties it generates, and the ultimate value of the company, is still high. Notably, Kodak may be collecting $1 billion in royalties soon.

The takeaway from the Eastman Kodak story is that it's important for technology companies to patent their inventions and protect their patents. Eastman Kodak's patents may be their only saving grace at this juncture.

Continue reading "Patents are the Heart of Many Companies - Eastman Kodak Case Study" »

Yesterday's Board of Patent Appeals and Interferences (BPAI) decision in Ex Parte Knox confirms what I've always thought about a "no motivation to combine" argument after the decision of KSR Int'l Co. v. Teleflex, Inc, - it's a narrow argument that doesn't have much punch.

The case of Ex parte Knox involved a computer program invention. The Examiner rejected the claims for being obvious in light of two prior art references - Lai and Bradshaw - under 35 U.S.C. § 103(a). Appellants presented a standard "no motivation to combine" argument.

The Board rejected this argument, first reciting case law that is often recited in BPAI decisions:

[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). The test of non-obviousness is not whether one reference can be bodily inserted into another, but, rather, what the references, when considered together, would have suggested to one of ordinary skill in the art, In re Keller, 642 F.2d 413, 425 (CCPA 1981), who is a person of ordinary creativity and not an automaton, KSR, 550 U.S. at 421, and whose inferences and creative steps we may consider, id. at 418.

If you ask me, this is pretty strong language that negates just about any "no motivation to combine" argument. The In re Keller holding appears to eliminate the need to show that two references can even be combined in a technical sense.

In light of the case law cited, the Board concluded the following:

We find that a person of ordinary skill in the art would have recognized that Bradshaw's technique of comparing first checksums with second checksums would improve Lai's file version recording ... We find that a person of ordinary skill in the art, using no more than ordinary skill and creativity, would have recognized that the calculation of a checksum ... could be performed using a checksum algorithm that is insensitive to the ordering of data, such as that taught by Lai

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The lesson learned from this case is that "no motivation to combine" arguments are not among the strongest arguments you can make at the BPAI. Seeing as the case law on combining prior art references is heavily weighted on the side of combining, I would leave this argument at the bottom of your toolbox along with the "non-analogous art" argument. Of course, every practitioner runs into tough situations at some point, and if you have nothing else, digging to the bottom of your toolbox is sometimes necessary.

Continue reading "Board of Patent Appeals Rejects "No Motivation to Combine" Argument Once More" »

Much has been written about the Pfizer Viagra patent. Recently, a District Court held the patent to be valid. All the fighting about this patent is directly related to Pfizer's $1 billion a year in U.S. Viagra sales. The patent itself has been valuated somewhere in the neighborhood of $10 billion.

But have you taken a look at the famous Pfizer Viagra patent? I did, and following are some interesting observations. Click here to see Pfizer's Viagra patent.

First, I am surprised to see how short the detailed description is. At less than six columns, it's one of the shorter patents out there. This goes to show, being brief is a virtue - even when you're dealing with a $10 billion patent. Second, notice how many pages of cited references there are. At 6 pages, that's a lot of references, and no doubt led to a stronger and more valuable patent. Lastly, note there are only two inventors. Though the testing and development of this drug probably cost somewhere in the billions of dollars and involved hundreds or thousands of people, it was only two guys that invented this drug and only two guys that will go down in history.

As inventors and developers of technology, we can only hope to have successful inventions. But it is certain that in order to realize a return on R&D investment, individuals and companies must pursue patents for their inventions. Thus, my recommendation to inventors and technology companies is to seriously consider pursuing patents for their inventions with the U.S. Patent and Trademark Office, especially in cases involving inventions that may generate significant revenue.

Continue reading "The Famous Pfizer Viagra Patent" »

Under the Federal Trademark Dilution Act, a famous trademark is one that has established a strong connection, in the minds of the consumers, between a specific good or service and the source of that good or service. For example, the Coca Cola brand has been determined to be a strong and famous mark. And with a valuation of over $67 billion, the Coca Cola brand is one of the most valuable and long lasting trademarks in the U.S.

Have you ever wondered what the original Coca Cola trademark registration looks like? Well, I looked it up at the U.S. Patent and Trademark Office and it's over one hundred years old.

Click here to see the first Coca Cola registration. There are a couple of interesting things to note about this trademark registration dating back to 1893. First, it is classified under "nutrient or tonic beverages." Clearly, people had a different idea of what constituted a nutritious food back then. Second, you can see that the stylized words are slightly different from the way they are used today on soda cans. Lastly, you can see the signatures of the original filers on the registration - a practice you don't see anymore at the Trademark Office.

As a trademark owner, we can only aspire to have a trademark with a value anywhere close to the value of Coca Cola's trademark. But it is telling that even in 1893, the owners of the Coca Cola Company knew the importance of registering their mark. Thus, my recommendation to any brand owner is to give serious thought to registering their trademark with the U.S. Patent and Trademark Office.

Continue reading "The Famous Coca Cola Trademark" »